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Evaluation of an Electronic CKD Clinical Decision Support System (CDSS) in Clinical Care (CDSSR18)

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ClinicalTrials.gov Identifier: NCT02925962
Recruitment Status : Recruiting
First Posted : October 6, 2016
Last Update Posted : May 2, 2018
Sponsor:
Information provided by (Responsible Party):
Carmen Alicia Peralta, University of California, San Francisco

Brief Summary:
The investigators propose a three-arm, pragmatic, cluster-randomized clinical trial based in primary care. Participating Primary Care Providers (PCPs) will be randomized to usual care or one of two intervention arms. The first intervention will evaluate the efficacy of an automated CDSS that utilizes the electronic health record (EHR) to facilitate triple marker test ordering, guideline implementation and BP management, compared with usual care, among patients with previous documentation of eGFRcreat <60 ml/min/1.73m2. The second intervention goes a step further, and will evaluate whether a CDSS plus a follow-up telephone call from a pharmacist (CDSS PLUS) can improve BP management and patient CKD and NSAID toxicity knowledge among the patients with CKD, compared with CDSS alone. The primary clinical outcome is BP level, with secondary outcomes related to processes of care and patient knowledge.

Condition or disease Intervention/treatment Phase
Hypertension Renal Insufficiency, Chronic Other: Clinical Decision Support System (CDSS) Other: Clinic Decision Sup System + Pharmacist Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 540 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: A Randomized Trial to Evaluate an Electronic CKD Clinical Decision Support System (CDSS) in Clinical Care
Actual Study Start Date : August 14, 2017
Estimated Primary Completion Date : December 31, 2018
Estimated Study Completion Date : June 30, 2019

Arm Intervention/treatment
Experimental: Clinical Decision Support System (CDSS)

PCPs get a notice the CKD Clinical Decision Support System (CDSS) is available.

CDSS overview:

  • The study MDs order CKD triple marker tests
  • Patients will go to the lab as per usual clinical care
  • Lab results are returned to PCPs clinical results folder as per usual clinical workflow with information about CKD and link to KDIGO guidelines
  • Results will also be sent to the Study MD's for monitoring
  • At the patient's next visit, if the labs are completed, the full CDSS launches for the PCP
  • If the labs are not completed by the next visit, a Best Practice Alert (BPA) will launch for the PCP notifying them that the labs have been ordered, but the patient hasn't done them yet
Other: Clinical Decision Support System (CDSS)
A targeted, automated CKD clinical decision support system (CDSS) designed to improve bloodpressure (BP) level, disease awareness, staging, processes of care, and knowledge among persons with documented reduced eGFRcreat (creatinine-based estimated glomerular filtration rate) in primary care setting.

Experimental: Clinic Decision Sup System + Pharmacist

The Clinical Decision Support System + Pharmacist follow-up call extends beyond the CDSS alone.

CDSS Plus overview:

  • At the visit in which the CDSS launches, the PCP will hand a study card with pharmacist information to their patient notifying them that a pharmacist will be calling to follow-up after the visit
  • The pharmacist will use MyChart and/or phone calls to schedule a follow-up call within two weeks of the visit
  • On the follow-up phone call, the pharmacist will discuss understanding of CKD, medication review and adherence assessment, home BP checks, and the importance of NSAID avoidance
  • A second follow-up call will only be scheduled if the patient is non-adherent with their medications and makes an active plan for adherence with the pharmacist, or if the patient requests an additional call from the pharmacist
Other: Clinic Decision Sup System + Pharmacist
Includes everything in the CDSS intervention but adds a follow-up call from a pharmacist, who is part of the clinical team. The rationale for this third arm is based on the evidence that clinical pharmacists have been shown to be more effective than physicians alone at achieving BP control in other settings.
Other Name: CDSS Plus, Clinical Decision Support System + Pharmacist

No Intervention: Usual Care
Patients continue to receive usual care by their provider.



Primary Outcome Measures :
  1. Change in blood pressure from enrollment [ Time Frame: Investigators will follow patients up to 2 years after measures ]
    Clinical Outcome: The primary clinical outcome of the trial is change in blood pressure (mmHg) from enrollment to the end of the follow up period as a continuous outcome, ascertained from the electronic medical record. BP measures from the clinical record will be ascertained in no more than quarterly intervals in the primary care setting to avoid bias by ascertainment. Investigators will also consider the dichotomous clinical outcome "achieved sustained BP control", defined as BP < 140/90 mmHg in ≥ two consecutive visits during the trial.


Secondary Outcome Measures :
  1. Feasibility [ Time Frame: Investigators will follow patients up to 2 years after measures ]
    Investigators will assess provider awareness of CKD, defined as percent appropriate inclusion of CKD in the problem list (dichotomous outcome).

  2. Processes of Care [ Time Frame: Investigators will follow patients up to 2 years after measures ]
    Investigators will also measure use of ACEI/ARB among persons with albuminuria, measured as the proportion (percent) of persons on these medications at the end of the study period, compared to enrollment. Medication prescription will be ascertained by percent with an electronic record of a new order or modification during the study period, not including refills. Other process outcomes relate to feasibility and the ability to implement the CDSS protocol. These include proportion in the intervention arms with completion of albuminuria and cystatin C testing.

  3. CKD and NSAID avoidance Knowledge [ Time Frame: Investigators will interview each participant 2 weeks after their primary care visit or clinical pharmacist phone call ]
    Patient-centered outcomes: Investigators will evaluate CKD and NSAID avoidance knowledge (proportion with correct answers), using structured telephone interviews, and comparing patients from the three study arms.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Have at least two outpatient, documented eGFRcreat values 30- 59 ml/min/1.72m2 that are at least ≥3 months apart
  • At least one of these measurements should be within 12 months.
  • Patients have seen their primary care physician at least one time within the previous 18 months
  • Patient's primary care providers agree to participate

Exclusion Criteria:

  • Patients actively and recently seen by nephrology clinic (at least once in the past 12 months)
  • Patients with a diagnosis of end stage renal disease
  • Persons aged >80
  • Persons with New York Heart Association (NYHA) class III or IV heart failure, known ejection fraction < 25%, or documented allergy to ace/arb.
  • Patients on dialysis, kidney transplant recipients and pregnant women
  • Patients with prevalent dementia, impaired cognition or severe mental illness; expected life expectancy < 6 months.

There will also be a category where the physician can opt out for specific patients in their panel due to not believing this person should be included in the study for any reason.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02925962


Contacts
Contact: Carmen A Peralta, MD, MAS 415-476-2173 CarmenAlicia.Peralta@ucsf.edu
Contact: Erica Day, MPH 4152214810 ext 23383 erica.day@va.gov

Locations
United States, California
UCSF Division of General Internal Medicine Recruiting
San Francisco, California, United States, 94115
Contact: Leah K Karliner, MD    415-353-7900    leah.karliner@ucsf.edu   
Contact: Sarita Pathak, MPH    415-502-1317    sarita.pathak@ucsf.edu   
Sponsors and Collaborators
University of California, San Francisco

Publications of Results:
Responsible Party: Carmen Alicia Peralta, MD, MAS, University of California, San Francisco
ClinicalTrials.gov Identifier: NCT02925962     History of Changes
Other Study ID Numbers: CP2016R18
First Posted: October 6, 2016    Key Record Dates
Last Update Posted: May 2, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Plan for monitoring data and safety: A recommendation to order a creatinine and potassium level following initiation or up-titration of ace/arb will be incorporated in the algorithm in the result note. A 24/7 line to a nephrology answering service will be available to participating Primary Care Providers (PCPs) in the case of critical results; for non-critical study-related questions, participating PCPs can contact the study nephrologist via staff messaging in APeX. If a patient is found to have eGFR < 30 ml/min/1.73m2, investigators will recommend nephrology referral for pre-dialysis care.

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Renal Insufficiency
Renal Insufficiency, Chronic
Kidney Diseases
Urologic Diseases